Celerion is a market leader in Early Cardiac Services, having completed over 40 TQT and more than 100 robust QT studies.
We have a thorough understanding of dosing requirements, study execution, design, and study-group sizes. If your next trial requires extensive cardiac monitoring, Celerion offers the expertise to guide you from development through submission.
For Thorough QT trials, Celerion offers the full suite of service offerings including protocol development, clinic conduct, ECG analysis, data management, fully integrated statistical analysis, study reports, regulatory submission support and ECG warehouse upload. These integrated services ensure production of the highest-quality data, turn-key operations and process efficiencies, which result in cost savings.
The implementation of the ICH E14 guidance has transformed cardiac monitoring in clinical trials. The “Thorough QT/QTc” or Definitive QT trial has become a critical component of EMEA and FDA approval submissions for the vast majority of small molecules and many biologics submissions for marketing authorizations, creating increased focus on cardiac monitoring and ECG quality throughout drug development.